Ferrocite Tablets

Basic Information

Product Label

Product label for Ferrocite Tablets
Full Name: Ferrocite Tablets
Brand: Breckenridge Pharmaceutical none
Product Type: Mineral
Physical State: Tablet or Pill
UPC/SKU: 3 51991 18142 2
Product Version Code: 5204-05-20

Contact Information

Manufactured by

Name: Contract Pharmacal Corp.
Address:135 Adams Avenue, Hauppauge, NY, 11788
Country: USA
Types: Manufacturer

Distributed by

Name: Breckenridge Pharmaceutical, Inc.
Address:Berlin, CT, 06037
Types: Distributor

Product Details

Net Contents

100 Tablet(s)(100 Tablet(s))
4 Blister Card(s)(4 Blister Card(s))

Serving Sizes

Unit:Tablet(s)
Quantity:1 - 1
Daily Servings:1 - 1

Target Groups

Adult (18 - 50 Years)

Servings Per Container

100

Ingredients & Nutrition

Iron

mineral

Notes: Iron (Form: from 324 mg of Ferrous Fumarate)

Amount: 106 mg
Serving Size: 1 Tablet(s)
Adults and children 4 or more years of age: 588%

Group: Iron

Citric Acid

non-nutrient/non-botanical

Group: Citric Acid

Group: Croscarmellose Sodium

Group: Color

Group: Color

Also known as: Tartrazine, tartrazine

Glyceryl Triacetate

non-nutrient/non-botanical

Group: Triacetin

Also known as: Triacetin

HPMC

other

Group: Hypromellose

Also known as: Hydroxypropylmethylcellulose, Hydroxypropyl Methyl Cellulose, Hydroxypropyl Methylcellulose, Hypromellose

Group: Hypromellose

Group: Magnesium stearate

MCC

other

Group: Cellulose

Also known as: Microcrystalline Cellulose

Group: Cellulose

Group: Sodium Lauryl Sulfate

Stearic Acid

fatty acid

Group: Stearic Acid

Also known as: C18:0

UNII Code: 4ELV7Z65AP

Group: Titanium Dioxide

Triacetin

non-nutrient/non-botanical

Group: Triacetin

Product Statements

Precautions re: Allergies

Contains FD&C Yellow No. 5 Lake (Tartrazine) as a color additive (see Precautions).

Precautions re: All Other

Warning: Do not exceed recommended dosage. The dietary supplementation of any anemic condition should be under the advice and supervision of a physician. Since oral iron products interfere with absorption of certain antibiotics, these products should not be taken within two hours of each other. Gastrointestinal disturbance (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and subside with continuation of therapy.

Precautions re: Pregnant or Nursing or Prescription Medications

Consult your doctor before use if you have, or have had, any health condition or if you are taking any medications (prescription or OTC).

Suggested/Recommended/Usage/Directions

Indication: For the dietary supplementation of iron deficiencies.

Precautions re: Allergies

Precautions This product contains FD&C Yellow No. 5 Lake (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 Lake (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Precautions re: Pregnant or Nursing or Prescription Medications

If pregnant, or planning to become pregnant or are currently breast-feeding, please contact your physician, or health-care provider before using or continuing use.

Suggested/Recommended/Usage/Directions

Dosage and Administration Usual adult dosage is one tablet daily, between meals, or as directed by a physician or health-care provider. Do not exceed recommended dosage. Do not administer to children.

Precautions re: All Other

Do not exceed recommended dosage.

General Statements: All Other Content

How Supplied Ferrocite Tablets are round, green, film-coated tablets debossed, “B181”. Supplied in boxes of 100 tablets (4 x 25). 51991-181-42

Precautions re: Children

Do not administer to children. Warning: Keep this and all medications out of the reach of children.

Storage

Storage: Store at 25 degrees C (77 degrees F); excursions permitted to 15 degrees - 30 degrees C (59 degrees - 86 degrees F). See USP Controlled Room Temperature. Protect from light and moisture.

General Statements: All Other Content

All substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Precautions re: All Other

Warning: Cancer and Reproductive Harm - www.P65Warnings.ca.gov

Precautions re: Children

Warning: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

FDA Disclaimer Statement

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Formula re: Contains

Iron (from 324 mg as Ferrous Fumarate)

Precautions re: All Other

Do not use if blister seals are broken

General Statements: All Other Content

Breckenridge A Towa company

FDA Statement of Identity

Dietary Supplement

General Statements: All Other Content

(4 Blister Cards with 25 Tablets each)

Precautions re: All Other

To report a serious adverse event contact: 1-800-367-3395.

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